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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Atrial Fibrillation Registry

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Study Status Progress Adequate
Application Number P030031 S011/ PAS002
Date Current Protocol Accepted 09/23/2011
Study Name OSB Lead-Atrial Fibrillation Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, multicenter, non-randomized clinical evaluation of PAF patients treated with the radio frequency ablation with Thermocool catheters.
Study Population Description Study Polulation: Adult patients with paroxysmal atrial fibrillation. Indication: For the treatment of paroxysmal atrial fibrillation.
Sample Size 381 patietns, 109 in the more-experienced physician group and 272 in the less-experienced physician group, 40 sites
Data Collection The primary safety endpoints include adverse events that occur within 7 days of an ablation procedure.
Follow-up Visits and Length of Follow-up Participants will be followed for 5-years.Participants will be asses prior to discharge, at the 1-month visit, and a yearly follow-up

OSB Lead-Atrial Fibrillation Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 mth report 02/12/2010 02/12/2010 On Time
1 year report 08/13/2010 08/13/2010 On Time
18 mth report 02/14/2011 02/14/2011 On Time
2 year report 08/12/2011 08/12/2011 On Time
3 year report 08/13/2012 08/08/2012 On Time
4 year report 08/12/2013 08/13/2013 Overdue/Received
5 year report 08/12/2014 08/08/2014 On Time
6 year report 08/12/2015 08/05/2015 On Time
7 year report 08/05/2016 08/05/2016 On Time
8 year report 09/30/2017 09/29/2017 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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